Acceptance of Vaginal Ring and Oral PrEP Increasing in Young African Women

By and large, young women and adolescent girls in Africa use and accept new methods of preventing sexually transmitted HIV, researchers reported.

Of the 247 adolescent girls and young women who participated in the REACH-034 trial, 77.8% had at least moderate adherence to use of the monthly dapivirine-eluting vaginal ring and 58.6% had at least moderate use of oral pre-exposure prophylaxis (PrEP), reported Gonasagrie Nair, MBChB, MPH, of the Centre for Medical Ethics and Law at Stellenbosch University in Cape Town, at a press conference during the virtual International AIDS Society Conference on HIV Science.

“What we saw in this study was that adherence was greater than what has been observed in previous studies,” she said. “And that was probably due to the counseling support provided with the study.”

Of the study participants, 97% used the ring some or all of the time, with just 3% not using it at all; 50% used the ring for a full month, Nair added. Twenty-two percent of the participants said they used PrEP all the time — meaning six to seven pills a week.

After 26 months of follow-up, one case of sexually transmitted HIV was detected, and four of the women were pregnant, she noted.

Additionally, 35% of the participants experienced at least one other sexually transmitted disease – 28.8% were infected with chlamydia and 8.5% were infected with gonorrhea.

The study was conducted in South Africa, Uganda, and Zimbabwe from February 2019 to April 2021. HIV-uninfected, non-pregnant participants ages 16-21 were enrolled across four clinical trial sites. About 35% of the group were adolescents. In the first two study phases, they were randomized to either the monthly dapivirine ring or daily oral tenofovir disoproxil fumarate/emtricitabine for 6 months, then switched to the other for 6 months.

The participants also received counseling, based on drug level feedback. In this analysis, Nair said, dapivirine levels indicating release of greater than 0.1071 mg/day were defined as moderate adherence and levels greater than 0.1426 mg/day as high adherence. Levels of tenofovir diphosphate in dried blood spots of greater than 700 fmol/punch were defined as moderate adherence and levels greater than 1,200 fmol/punch as high adherence.

Adverse events of grade 2 or higher were experienced by 78% of the participants, but Nair noted that 94.4% have remained in the trial. The researchers observed no safety concerns with either the ring or PrEP.

Acceptability of the preventive measures varied, with 88.5% of the group saying they liked the vaginal ring method and 63.9% reporting that they liked the use of oral PrEP, she added.

“We undertook this study because adolescent girls and young women continue to be at great risk of acquiring HIV infection,” Nair said. “Safe and effective methods that can and will be used by young women are critical. Daily oral PrEP has been approved in many countries and the dapivirine vaginal ring is undergoing regulatory review in several countries currently. But these methods and products will only work if used consistently, and young women have had challenges in complying with both oral PrEP and the vaginal ring, as seen in past clinical trials.”

“The interim results from the REACH study show that adolescent girls and young women can and will use both oral PrEP and the dapivirine vaginal ring,” she continued.

“This study gives us encouraging news. Adolescent girls and young women account for most of the new HIV infections in sub-Saharan Africa, and the WHO has recently endorsed the vaginal ring and oral PrEP to reduce substantial risk of HIV infection,” said press conference moderator and president of the International AIDS Society, Adeeba Kamarulzaman, MBBS, of the University of Malaya in Kuala Lumpur, Malaysia.

“We hope that these findings will help accelerate efforts to make both these two preventive options available, so all girls and young women can benefit,” she added.